Ignite Creation Date:
2024-07-17 @ 10:54 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06473246
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-03
Brief Title:
A Study to Determine Safety Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants
Sponsor:
Vedic Lifesciences Pvt Ltd
Organization:
Vedic Lifesciences Pvt Ltd
Study Overview
Official Title:
A Randomized Double-blind Placebo Controlled Parallel Study to Determine Safety Pharmakokinetics and Efficacy of the Different Doses of VL-SE-01 in Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The present study is a randomized placebo-controlled parallel study 250 participants will be screened and considering a screening failure rate of 20 approximately 200 participants will be randomized in a ratio of 11111 to receive either different doses of VL-SE-01 or placebo and will be assigned a unique randomization code Each group will have at least 30 participants total 150 completers after accounting for a dropoutwithdrawal rate of 25 The intervention duration for all the study participants is 180 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None